NCT00003257

Brief Summary

RATIONALE: Inserting the gene for p53 into a person's tumor may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have recurrent head and neck cancer.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.9 years until next milestone

First Posted

Study publicly available on registry

September 10, 2004

Completed
Last Updated

December 4, 2013

Status Verified

April 1, 2000

First QC Date

November 1, 1999

Last Update Submit

December 3, 2013

Conditions

Head and Neck Cancer

Keywords

recurrent metastatic squamous neck cancer with occult primaryrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Interventions

Ad5CMV-p53 geneBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck (SCCHN) Recurrent disease documented by histology or cytology (excluding endolaryngeal recurrence) following first line therapy with curative intent, such as: Radiation (at least 5000 cGy by standard methodology) and/or Surgery (definitive resection with postoperative radiation as indicated) Lesions accessible to intratumoral injections Bidimensionally measurable disease The sum of the products of the bidirectional measurements for all bidimensionally measurable lesions must be not greater than 30 cm2 The sum of the longest diameters of all measurable lesions must be not greater than 10 cm No CNS metastasis Tumor tissue from biopsy of primary or recurrent tumor must be available to determine p53 mutation status PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 2,000/mm3 Hepatic: Total bilirubin no greater than upper limit of normal (ULN) AST/SGOT and/or ALT/SGPT no greater than 1.5 times ULN Alkaline phosphatase no greater than 5 times ULN Renal: Not specified Other: Not pregnant or nursing Barrier contraception required during treatment Negative for HIV 1, HIV 2, hepatitis B, and hepatitis C At least 2 years since prior malignancy, other than SCCHN No contact with former tissue or organ transplant recipients or persons with severe immunodeficiency disease within 28 days following final dose of study drug No serious concurrent medical conditions No active uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunostimulating drugs No prior autologous or allogeneic organ or tissue transplant Chemotherapy: At least 4 weeks since prior chemotherapy At least 6 weeks since nitrosourea or mitomycin No other concurrent chemotherapy Endocrine therapy: No concurrent nontopical corticosteroids unless chronic (at least 6 months) at low doses (no greater than 10 mg of oral prednisone) Radiotherapy: See Disease Characteristics At least 4 weeks since radiotherapy to measurable disease sites, unless progressive disease No concurrent radiotherapy to disease sites receiving study drug injections Surgery: See Disease Characteristics No concurrent surgery to disease sites receiving study drug injections Other: No concurrent high dose steroids At least 4 weeks since experimental therapy No concurrent other experimental drugs or therapy No prior gene therapy using adenoviral vectors

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Sidney Kimmel Cancer Center

San Diego, California, 92121, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

University of Connecticut School of Medicine

Farmington, Connecticut, 06032, United States

Location

Clinical Sciences Building

Chicago, Illinois, 60612, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

advexin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Lyndah Dreiling, MD

    Aventis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 10, 2004

Study Start

January 1, 1998

Last Updated

December 4, 2013

Record last verified: 2000-04

Locations

US(10)